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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 11/13/19-11/14/19

Meeting Details:

On November 13 and 14, 2019, the committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. Implants are medical devices that are placed into a surgically or naturally formed opening of the human body and are intended to remain there after the procedure for an extended period of time (typically, greater than 30 days). For decades, metal-containing implants have been used in a large number of medical specialties including cardiology, orthopedics, dentistry, gastroenterology, and neurology or neurosurgery. Recent postmarket issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological responses to the implant. These may include local (peri-implant) adverse events and potentially systemic manifestations, which may impact a patient's quality of life and necessitate medical or surgical intervention. While not considered an implant, dental amalgam is included in this discussion because of its potential for patient and user exposure to mercury compounds and some purported similarities in the adverse biological responses and clinical manifestations elicited by some dental amalgams to that of traditional metal implants.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting Postponed: Immunology Devices Panel

Meeting Date: 10/14/11-10/14/11

Meeting Details:

On October 14, 2011, the committee will discuss, make recommendations, and vote on a premarket approval application for the Progensa PCA3 assay sponsored by Gen-Probe, Inc. The Progensa PCA3 assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care, before consideration of PCA3 assay results. A lower PCA3 score is associated with a decreased likelihood of a positive biopsy.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 12/3/08-12/3/08

Meeting Details:

The committee will discuss and make recommendations on the premarket notification application for the Fujirebio HE4 EIA kit and associated Risk of Malignancy algorithm (ROMA\TM\) Test. The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The HE4 EIA, used in conjunction with the ARCHITECT CA 125 II assay, creates a predictive probability of epithelial ovarian cancer using a mathematical function referred to as the ROMA\TM\, for use in premenopausal and postmenopausal women presenting with an adnexal mass who have already been referred to an oncologic specialist and are scheduled for surgery. Subjects categorized as low risk for epithelial ovarian cancer using the ROMA\TM\ value may have surgical intervention performed by a non-oncology specialist. The results must be interpreted in conjunction with other clinical findings in accordance with standard clinical management guidelines. The assay is not indicated as an aid in a decision to proceed to surgery.

 

       
Location: Hilton Washington DC North/Gaithersburg Gaithersburg, MD. Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 11/16/06-11/16/06

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for a laboratory assay designed for the rapid detection of clinically relevant (greater than 0.2 millimeters) metastases in lymph node tissue removed from breast cancer patients. Results from the assay can be used to guide the surgeon’s decision to excise additional lymph nodes and aid in staging.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 7/15/05-7/15/05

Meeting Details:

The committee will hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. The committee will also discuss, make recommendations, and vote on a premarket approval application for a laboratory assay designed to measure levels of neural thread protein in urine specimens from patients presenting with cognitive complaints or other signs and symptoms of suspected Alzheimer’s disease. Results from this test are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, to aid the physician in the differential diagnosis of Alzheimer’s disease.

 

       
Location: HOL - Bethesda Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices

Meeting Date: 12/13/99-12/13/99

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an enzyme immunoassay (EIA) to be used as an aid in the diagnosis of patients with transitional cell carcinoma of the urinary tract.

 

       
Location: Corporate Bldg. Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsImmunology Devices Panel

Meeting Date: 11/9/98-11/9/98

Meeting Details:

The committee will discuss, make recommendations, and vote on apremarket approval application (PMA) for a fluorescence in situ hybridization(FISH) assay used in the detection of amplification of the HER-2/neu gene from subjects with node positive, stage II breast cancer to aid in the assessment of response to adjuvant therapy.

 

       
Location: FDA Corporate Building, Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntiviral Drugs Advisory Committee

Meeting Date: 3/30/95-3/31/95

Meeting Details:

On March 30, 1995, the subcommittee will discuss data relevant to NDA 20-513 (250 milligrams (mg) capsules) and NDA 20-514 (500 mg tablets), for mycophenolate mofetil (CellCept, Syntex Laboratories, Inc.), for use in the prophylaxis of organ rejection and treatment of refractory organ rejection in patients receiving allergenic renal transplants. On March 31, 1995, the subcommittee will discuss data relevant to NDA 50-715 (soft gelatin capsules) and NDA 50-716 (oral solution) for cyclosporine microemulsion (Neoral, Sandoz Pharmaceuticals Corp.) for prophylaxis of organ rejection in kidney, liver, and heart allergenic transplants.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the MDAC

Meeting Date: 10/27/20-10/27/20

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Meeting Details:

On October 27, 2020, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Neovasc Reducer System sponsored by Neovasc, Inc. The proposed Indication for Use of the Neovasc Reducer System is for patients suffering from refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 10/22/20-10/22/20

Meeting Details:

On October 22, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPatient Engagement Advisory Committee

Meeting Date: 10/22/20-10/22/20

Meeting Details:

On October 22, 2020, the committee will discuss and make recommendations on the topic “Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices.” Specifically, we will discuss the composition of the datasets on which the software “learns”, components of the device information shared with patients, and factors that impact patient trust in the technology. Large clinical datasets are used to train and improve AI/ML algorithms, allowing transformational improvements in the diagnosis, clinical decision making, and treatment of patients. Devices using AI/ML technology will transform healthcare delivery by increasing efficiency of key processes in the treatment of patients. Health products powered by AI/ML are streaming into our lives, from virtual doctor apps to wearable sensors and drugstore chatbots to algorithms for detecting cancer in mammography and interpretations of chest X rays. Despite the rapid advancement and integration, AI/ML systems may have algorithmic biases, limited generalizability, and lack transparency in their assumptions based on potential limitations of training datasets. The recommendations provided by the committee will address the importance of including various demographic groups in AI/ML algorithm development. The recommendations will also address the impact of the user interface and transparency including what information and how the information about the devices could be communicated to foster patient trust in the AI/ML devices.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSaRM AdComm

Meeting Date: 10/9/20-10/9/20

Meeting Details:

The committees will discuss the efficacy, safety, and benefit-risk profile of new drug application (NDA) 213378, olanzapine and samidorphan oral tablets, submitted by Alkermes, Inc., for the proposed indications of schizophrenia and bipolar disorder.

 

       
Location: FDA TelCon - Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 10:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Psychopharmacologic & DSaRM AdComm

Meeting Date: 10/8/20-10/8/20

Meeting Details:

The committees will discuss new drug application (NDA) 211179, for amphetamine sulfate immediate-release oral capsules, submitted by Arbor Pharmaceuticals, LLC, for the proposed indication of treatment of attention deficit hyperactivity disorder. The product has been formulated with properties intended to deter non-oral abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, including the potential public health impact, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel of the MDAC

Meeting Date: 10/7/20-10/7/20

Meeting Details:

On October 7, 2020, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the TransMedics Organ Care System (OCS)--Heart, by TransMedics, Inc. The proposed Indication for Use for the TransMedics OCS--Heart, as stated in the PMA, is as follows: The TransMedics OCS Heart System is a portable ex-vivo organ perfusion and monitoring system indicated for the resuscitation, preservation, and assessment of donor hearts with one or more of the following characteristics for transplantation into a potential recipient in a near-physiologic, normothermic, and beating state: Expected cross-clamp or ischemic time = 4 hours due to donor or recipient characteristics (e.g., donor-recipient geographical distance, expected recipient surgical time) Donor Age = 55 years Donors with history cardiac arrest and downtime = 20 minutes Donor history of alcohol use Donor LV Ejection Fraction = 50 percent but = 40 percent Donor history of Left Ventricular Hypertrophy (septal or posterior wall thickness of >12 and = 16 millimeters).

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform held via webcast only. Related News Links: Not Available
Time: 9:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 10/2/20-10/2/20

Meeting Details:

On October 2, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss and make recommendations on selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 11:00AM-3:30PM    
Materials:
   
       

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Past Meetings

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